French Competition Authority probes Sanofi-Aventis alleged abuse against generic manufacturers

On 17 May 2010, the French Autorité de la concurrence (French Competition Authority, “FCA”) determined to open a fully fledged investigation (under Article 102 TFEU) into Sanofi-Aventis allegedly abusive practices aimed at preventing generic competition to its blockbuster Plavix following a complaint by Teva Santé, the leading Israeli generics manufacturer.  The FCA rejected the request for interim measures claimed by Teva Santé.

In November 2009, Teva Santé complained, inter alia, about Sanofi-Aventis marketing practices, using the differences between Plavix and competing generics in order to denigrate competing generic medications amongst physicians and pharmacists.
In particular, in its commercial presentations to physicians and pharmacists, Sanofi-Aventis would appear to have emphasized the differences that exist between its reference and competing generics (other than its own), without indicating that their total bioequivalence has been recognized by health authorities (i.e. the generic formulation has been fully tested and approved for use by medical authorities across Europe) and that these differences are of no therapeutic relevance.

In its decision, the FCA considers that denigratory practices are susceptible to amount to an abuse of dominance.  The FCA recalled that in a previous case, it had already held that it is not for a dominant undertaking to carry out the task of health authorities, further noting that according to the European Commission’s Guidance on enforcement priorities in applying Article 82 of the EC Treaty (now Article 102 TFEU) “It is not the task of a dominant undertaking to take steps on its own initiative to exclude products which it regards, rightly or wrongly, as dangerous or inferior to its own product.”

The FCA continues that while it is perfectly permissible for a laboratory to demonstrate the objective qualities of a product, by letting it be understood, in an implicit but necessary manner, that these differences have an impact on the product’s safety and efficiency, and therefore on the patient’s health, the Sanofi-Aventis laboratory is encouraging health care professionals not to prescribe or replace the original with anything other than the laboratory’s own generic.

According to the FCA, Sanofi-Aventis’s behaviour may be regarded, at this stage of the investigation, as not a legitimate business conduct aimed at defending its interests against the entry of generics competing with Plavix, and must be investigated further. [Gabriele Accardo]